TX-3 SD— 510(k) K923934

Substantially Equivalent

Skylark Device Co., Ltd.

FDA 510(k) clearance K923934 for TX-3 SD, Substantially Equivalent on 1992-10-23. Applicant: Skylark Device Co., Ltd.. Device class: 2.

Clearance details

Applicant
Skylark Device Co., Ltd.
Product code
Code GZJ
Device class
Class 2
Regulation
21 CFR 882.5890
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Taipei, Taiwan, R.O.C., TW
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